Traditionally, low back-related leg pain (LBLP) is diagnosed clinically as referred leg pain or s... more Traditionally, low back-related leg pain (LBLP) is diagnosed clinically as referred leg pain or sciatica (nerve root involvement). However, within the spectrum of LBLP, we hypothesised that there may be other unrecognised patient subgroups. This study aimed to identify clusters of patients with LBLP using latent class analysis and describe their clinical course. The study population was 609 LBLP primary care consulters. Variables from clinical assessment were included in the latent class analysis. Characteristics of the statistically identified clusters were compared, and their clinical course over 1 year was described. A 5 cluster solution was optimal. Cluster 1 (n 5 104) had mild leg pain severity and was considered to represent a referred leg pain group with no clinical signs, suggesting nerve root involvement (sciatica). Cluster 2 (n 5 122), cluster 3 (n 5 188), and cluster 4 (n 5 69) had mild, moderate, and severe pain and disability, respectively, and response to clinical assessment items suggested categories of mild, moderate, and severe sciatica. Cluster 5 (n 5 126) had high pain and disability, longer pain duration, and more comorbidities and was difficult to map to a clinical diagnosis. Most improvement for pain and disability was seen in the first 4 months for all clusters. At 12 months, the proportion of patients reporting recovery ranged from 27% for cluster 5 to 45% for cluster 2 (mild sciatica). This is the first study that empirically shows the variability in profile and clinical course of patients with LBLP including sciatica. More homogenous groups were identified, which could be considered in future clinical and research settings.
evaluating the predictive ability and clinical utility of the SBST in a population with exclusive... more evaluating the predictive ability and clinical utility of the SBST in a population with exclusively chronic low back pain. Purpose: To determine the predictive ability and prognostic accuracy of the SBST for persistent pain, self-reported disability and self-perceived global rating of change in an Australian population with exclusively chronic low back pain. Methods: The SBST was completed at baseline by 290 participants with dominantly axial non-specific low back pain of at least three months duration. Follow-up data was collected after one year (n ¼ 264) for pain severity (11-point numerical rating scale), disability (Roland Morris Disability Questionnaire) and global perceived change (7-point global rating of change scale). The follow-up measures were dichotomised into recovered and not recovered for analyses. The proportion of participants who were not recovered with respect to each follow-up measure was calculated at a cohort level and by baseline SBST risk subgroup. Risk ratios (RR) (using the low risk group as the reference group) were calculated and ROC analyses performed. Results: At baseline, the SBST characterised 82 participants (28.3%) as low risk, 116 (40.0%) as medium risk and 92 (31.7%) as high risk. Non-recovery rates at one year were 31.4% (n ¼ 83) for disability, 76.1% (n ¼ 201) for pain and 44.5% (n ¼ 117) for global perceived change. The predictive ability of the SBST was strongest for disability (RR medium risk group 2.30 (95% CI 1.28e4.10), p ¼ 0.003; RR high risk group 2.86 (95% CI 1.60e5.11), p 0.001) and weaker for pain (RR medium risk group 1.25 (95% CI 1.04e1.51), p ¼ 0.013; RR high risk group 1.26 (95% CI 1.03e1.52, p ¼ 0.020). The AUC for disability was acceptable at 0.71 (95% CI 0.64e0.77) for the SBST total score and 0.67 (95% CI 0.60e0.73) for the psychological subscale score. The AUC for pain was poor (0.63 (95% CI 0.55e0.71)) for both the total score and psychological sub-scale score. The SBST risk subgroups were unable to identify those who had rated themselves as improved or not improved at one year. Conclusion: Baseline stratification with the SBST provided some indication of overall disability risk but its ability to predict future disability was attenuated compared to that previously reported in UK primary care with variable duration low back pain. In this study the SBST was relatively poor in predicting future pain and was unable to discriminate between those who perceived themselves as improved or not at one year. Implications: The SBST should be applied with caution in patients presenting with chronic low back pain. Clinicians interested in predicting future pain or global perceived change should consider using alternative screening measures in this population. It is recommended that the SBST be used in context with the clinical examination and in conjunction with sound clinical reasoning, clinical intuition and expert judgement, not as a standalone tool.
Programme grants for applied research, Jun 1, 2023
Background: Usual primary care for patients with musculoskeletal pain varies widely and treatment... more Background: Usual primary care for patients with musculoskeletal pain varies widely and treatment outcomes are suboptimal. Stratified care involves targeting treatments according to patient subgroups, in the hope of maximising treatment benefit and reducing potential harm or unnecessary interventions. This programme developed a new prognostic stratified primary care approach, where treatments are matched to a patient's risk of future persistent pain and disability based on a prognostic tool, and compared this with usual care. Objectives: In four linked work packages, we refined and validated a prognostic tool [the Keele STarT MSK (Subgrouping for Targeted Treatment for Musculoskeletal pain) Tool] to identify risk of poor outcome and defined cutoff scores to distinguish patient risk subgroups (work package 1); defined and agreed new matched treatment options for each risk subgroup and developed a support package for delivery of stratified care (work package 2); tested the feasibility of delivering the stratified approach through a pilot randomised controlled trial and externally validated the prognostic tool (work package 3); and tested the effectiveness of the approach by comparing the clinical effectiveness and costeffectiveness of stratified primary care with that of usual care through a cluster randomised controlled trial with embedded health economic and qualitative studies (work package 4). Setting: General practices and linked musculoskeletal services in the West Midlands of England, UK. Participants: Adults registered with participating practices consulting with back, neck, shoulder, knee or multisite musculoskeletal pain, and clinicians involved in managing these patients. Design: The programme included the following work packages: work package 1-a prospective cohort study in 12 practices; work package 2-an evidence synthesis, consensus group workshops and qualitative studies; work package 3-a cluster feasibility and pilot trial in eight practices; and work viii NIHR Journals Library www.journalslibrary.nihr.ac.uk ABSTRACT package 4-a main cluster randomised controlled trial in 24 practices, with health economic analyses and process evaluation. Interventions: Stratified care comprised training general practitioners to use the tool and match patients to treatment options depending on their risk subgroup. Usual care comprised usual nonstratified primary care without formal stratification tools. Main outcome measures: Cohort primary end points included function (Short Form questionnaire-36 items physical component score) and pain intensity (numerical rating scale). The trial primary end point for patient outcomes was pain intensity (monthly for 6 months) (0-10 numerical rating scale). An audit of primary care electronic medical records evaluated the impact of stratified care on clinical decisionmaking regarding patient management. Results: Work package 1-the cohort study (n = 1890 patients) refined and validated a new 10-item tool with which to stratify patients with the five most common musculoskeletal pain presentations. The tool subgroups patients into three strata with different characteristics and prognoses. Work package 2: 17 treatment options were recommended-four for patients at low risk, 10 for patients at medium risk and 15 for patients at high risk. Work package 3: the feasibility and pilot trial included 524 patients, and the learning led to amendments to several tool items and a reduced set of treatments (14 in total). Work package 4: in the main trial, 1211 patients consented to data collection (534 in stratified care, 677 in usual care). Stratified primary care did not lead to statistically significant differences in the primary patient outcome of pain intensity [stratified care mean 4.4 (standard deviation 2.3) vs. usual care mean 4.6 (standard deviation 2.4); adjusted mean difference-0.16, 95% confidence interval-0.65 to 0.34; p = 0.535]. Where differences were observed, these were largely isolated to patients at high risk of poor outcome (the smallest subgroup), in favour of stratified care. Positive differences were, however, observed in general practitioner clinical decision-making, with increased provision of written selfmanagement information and referrals to physiotherapy, plus reductions in prescription medication. The economic evaluation demonstrated that costs of care were similar across trial arms (£6.85, 95% confidence interval-£107.82 to £121.54 more for stratified care), with incremental quality-adjusted life-years of 0.0041 (95% confidence interval-0.0013 to 0.0094), representing a net quality-adjusted life-year gain. Stratified care was associated with an incremental cost-effectiveness ratio of £1670 per additional quality-adjusted life-year gained. At a willingness-to-pay threshold (λ) of £20,000 per qualityadjusted life-year, the incremental net monetary benefit was £132 and the probability of stratified care being cost-effective was approximately 73%. The very small differences suggest caution in the interpretation of this result. The qualitative findings revealed that general practitioners felt stratified care had a positive role in informing clinical decision-making, helped them to give greater attention to psychosocial issues and take a more functional approach, and facilitated negotiations with patients about treatment options such as imaging. Limitations: The randomised controlled trial was not powered to detect differences between stratified and usual care for patients in each risk subgroup (low, medium and high) nor with each different musculoskeletal pain presentation. The stratified care electronic medical record template 'fired' only once per patient. Conclusions: The Keele STarT MSK Tool is a valid instrument with which to discriminate between, and predict outcomes of, primary care patients with musculoskeletal pain. Although the randomised trial showed no significant benefit in patient-reported outcomes compared with usual care, some aspects of clinical decision-making improved and the approach was cost-effective. Future work: The Keele STarT MSK Tool has been shared with over 1000 tool license requestees, leading to other work. Trial data sets have also led to other work, developing personalised prognostic models for back and neck pain patients (the European Union-funded BackUP project). The challenge remains how to improve outcomes for primary care patients with musculoskeletal pain. Trial registration: This trial is registered as ISRCTN15366334.
Link to publication on Research at Birmingham portal General rights Unless a licence is specified... more Link to publication on Research at Birmingham portal General rights Unless a licence is specified above, all rights (including copyright and moral rights) in this document are retained by the authors and/or the copyright holders. The express permission of the copyright holder must be obtained for any use of this material other than for purposes permitted by law. • Users may freely distribute the URL that is used to identify this publication. • Users may download and/or print one copy of the publication from the University of Birmingham research portal for the purpose of private study or non-commercial research. • User may use extracts from the document in line with the concept of 'fair dealing' under the Copyright, Designs and Patents Act 1988 (?) • Users may not further distribute the material nor use it for the purposes of commercial gain. Where a licence is displayed above, please note the terms and conditions of the licence govern your use of this document. When citing, please reference the published version. Take down policy While the University of Birmingham exercises care and attention in making items available there are rare occasions when an item has been uploaded in error or has been deemed to be commercially or otherwise sensitive.
Background: There is limited research on the economic burden of low back-related leg pain, includ... more Background: There is limited research on the economic burden of low back-related leg pain, including sciatica. The aim of this study was to describe healthcare resource utilisation and factors associated with cost and health outcomes in primary care patients consulting with symptoms of low back-related leg pain including sciatica. Methods: This study is a prospective cohort of 609 adults visiting their family doctor with low back-related leg pain, with or without sciatica in a United Kingdom (UK) Setting. Participants completed questionnaires, underwent clinical assessments, received an MRI scan, and were followed-up for 12-months. The economic analysis outcome was the quality-adjusted life year (QALY) calculated from the EQ-5D-3 L data obtained at baseline, 4 and 12-months. Costs were measured based on patient self-reported information on resource use due to back-related leg pain and results are presented from a UK National Health Service (NHS) and Societal perspective. Factors associated with costs and outcomes were obtained using a generalised linear model. Results: Base-case results showed improved health outcomes over 12-months for the whole cohort and slightly higher QALYs for patients in the sciatica group. NHS resource use was highest for physiotherapy and GP visits, and work-related productivity loss highest from a societal perspective. The sciatica group was associated with significantly higher work-related productivity costs. Cost was significantly associated with factors such as self-rated general health and care received as part of the study, while quality of life was significantly predicted by self-rated general health, and pain intensity, depression, and disability scores. Conclusions: Our results contribute to understanding the economics of low back-related leg pain and sciatica and may provide guidance for future actions on cost reduction and health care improvement strategies. Trial registration: 13/09/2011 Retrospectively registered; ISRCTN62880786.
Background: Musculoskeletal (MSK) pain from the five most common presentations to primary care (b... more Background: Musculoskeletal (MSK) pain from the five most common presentations to primary care (back, neck, shoulder, knee or multi-site pain), where the majority of patients are managed, is a costly global health challenge. At present, first-line decision-making is based on clinical reasoning and stratified models of care have only been tested in patients with low back pain. We therefore, examined the feasibility of; a) a future definitive cluster randomised controlled trial (RCT), and b) General Practitioners (GPs) providing stratified care at the point-ofconsultation for these five most common MSK pain presentations. Methods: The design was a pragmatic pilot, two parallel-arm (stratified versus non-stratified care), cluster RCT and the setting was 8 UK GP practices (4 intervention, 4 control) with randomisation (stratified by practice size) and blinding of trial statistician and outcome data-collectors. Participants were adult consulters with MSK pain without indicators of serious pathologies, urgent medical needs, or vulnerabilities. Potential participant records were tagged and individuals sent postal invitations using a GP point-of-consultation electronic medical record (EMR) template. The intervention was supported by the EMR template housing the Keele STarT MSK Tool (to stratify into low, medium and high-risk prognostic subgroups of persistent pain and disability) and recommended matched treatment options. Feasibility outcomes included exploration of recruitment and follow-up rates, selection bias, and GP intervention fidelity. To capture recommended outcomes including pain and function, participants completed an initial questionnaire, brief monthly questionnaire (postal or SMS), and 6-month follow-up questionnaire. An anonymised EMR audit described GP decision-making. Results: GPs screened 3063 patients (intervention = 1591, control = 1472), completed the EMR template with 1237 eligible patients (intervention = 513, control = 724) and 524 participants (42%) consented to data collection (intervention = 231, control = 293). Recruitment took 28 weeks (target 12 weeks) with > 90% follow-up retention (target > 75%). We detected no selection bias of concern and no harms identified. GP stratification tool fidelity failed to achieve a-priori success criteria, whilst fidelity to the matched treatments achieved "complete success". Conclusions: A future definitive cluster RCT of stratified care for MSK pain is feasible and is underway, following key amendments including a clinician-completed version of the stratification tool and refinements to recommended matched treatments.
Background: Musculoskeletal (MSK) pain represents a considerable worldwide healthcare burden. Thi... more Background: Musculoskeletal (MSK) pain represents a considerable worldwide healthcare burden. This study aimed to gain consensus from practitioners who work with MSK pain patients, on the most appropriate primary care treatment options for subgroups of patients based on prognostic risk of persistent disabling pain. Agreement was sought on treatment options for the five most common MSK pain presentations: back, neck, knee, shoulder and multisite pain, across three risk subgroups: low, medium and high. Methods: Three consensus group meetings were conducted with multidisciplinary groups of practitioners (n = 20) using Nominal Group Technique, a systematic approach to building consensus using structured in-person meetings of stakeholders which follows a distinct set of stages. Results: For all five pain presentations, "education and advice" and "simple oral and topical pain medications" were agreed to be appropriate for all subgroups. For patients at low risk, across all five pain presentations "review by primary care practitioner if not improving after 6 weeks" also reached consensus. Treatment options for those at medium risk differed slightly across pain-presentations, but all included: "consider referral to physiotherapy" and "consider referral to MSK-interface-clinic". Treatment options for patients at high risk also varied by pain presentation. Some of the same options were included as for patients at medium risk, and additional options included: "opioids"; "consider referral to expert patient programme" (across all pain presentations); and "consider referral for surgical opinion" (back, knee, neck, shoulder). "Consider referral to rheumatology" was agreed for patients at medium and high risk who have multisite pain. Conclusion: In addressing the current lack of robust evidence on the effectiveness of different treatment options for MSK pain, this study generated consensus from practitioners on the most appropriate primary care treatment options for MSK patients stratified according to prognostic risk. These findings can help inform future clinical decision-making and also influenced the matched treatment options in a trial of stratified primary care for MSK pain patients.
Objectives: The aim of this study was to describe and compare health economic outcomes [health-ca... more Objectives: The aim of this study was to describe and compare health economic outcomes [health-care utilization and costs, work outcomes, and health-related quality of life (EQ-5D-5L)] in patients classified into different levels-of-risk subgroups by the Keele STarT MSK Tool. Methods: Data on health-care utilization, costs and EQ-5D-5L were collected from a health-care perspective within a primary care prospective observational cohort study. Patients presenting with one (or more) of the five most common musculoskeletal pain presentations were included: back, neck, shoulder, knee or multi-site pain. Participants at low, medium and high risk of persistent disabling pain were compared in relation to mean health-care utilization and costs, health-related quality of life, and employment status. Regression analysis was used to estimate costs. Results: Over 6 months, the mean (S.D.) total health-care (National Health Service and private) costs associated with the low, medium, and highrisk subgroups were £132.92 (167.88), £279.32 (462.98) and £476.07 (716.44), respectively. Mean health-related quality of life over the 6-month period was lower and more people changed their employment status in the high-risk subgroup compared with the medium-and low-risk subgroups. Conclusions: This study demonstrates that subgroups of people with different levels of risk for poor musculoskeletal pain outcomes also have different levels of health-care utilization, health-care costs, health-related quality of life, and work outcomes. The findings show that the STarT MSK Tool not only identifies those at risk of a poorer outcome, but also those who will have more health-care visits and incur higher costs.
1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/formResponse?hl=en_US 3/22 yes: all prim... more 1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/formResponse?hl=en_US 3/22 yes: all primary outcomes were significantly better in intervention group vs control partly: SOME primary outcomes were significantly better in intervention group vs control no statistically significant difference between control and intervention potentially harmful: control was significantly better than intervention in one or more outcomes
BackgroundWhile there is a substantial body of knowledge about acute COVID-19, less is known abou... more BackgroundWhile there is a substantial body of knowledge about acute COVID-19, less is known about long-COVID, where symptoms continue beyond 4 weeks.AimTo describe longer-term effects of COVID-19 infection in children and young people (CYP) and identify their needs in relation to long-COVID.Design & settingThis study comprises an observational prospective cohort study and a linked qualitative study, identifying participants aged 8–17 years in the West Midlands of England.MethodCYP will be invited to complete online questionnaires to monitor incidences and symptoms of COVID-19 over a 12-month period. CYP who have experienced long-term effects of COVID will be invited to interview, and those currently experiencing symptoms will be asked to document their experiences in a diary. Professionals who work with CYP will be invited to explore the impact of long-COVID on the wider experiences of CYP, in a focus group. Descriptive statistics will be used to describe the incidence and rates of...
BackgroundPatients with musculoskeletal pain in different body sites share common prognostic fact... more BackgroundPatients with musculoskeletal pain in different body sites share common prognostic factors. Using prognosis to stratify and treatment match can be clinically and cost‐effective. We aimed to refine and validate the Keele STarT MSK Tool for prognostic stratification of musculoskeletal pain patients.MethodsTool refinement and validity was tested in a prospective cohort study, and external validity examined in a pilot cluster randomized controlled trial (RCT). Study population comprised 2,414 adults visiting U.K. primary care with back, neck, knee, shoulder or multisite pain returning postal questionnaires (cohort: 1,890 [40% response]; trial: 524). Cohort baseline questionnaires included a draft tool plus refinement items. Trial baseline questionnaires included the Keele STarT MSK Tool. Physical health (SF‐36 Physical Component Score [PCS]) and pain intensity were assessed at 2‐ and 6‐month cohort follow‐up; pain intensity was measured at 6‐month trial follow‐up.ResultsThe to...
Link to publication on Research at Birmingham portal General rights Unless a licence is specified... more Link to publication on Research at Birmingham portal General rights Unless a licence is specified above, all rights (including copyright and moral rights) in this document are retained by the authors and/or the copyright holders. The express permission of the copyright holder must be obtained for any use of this material other than for purposes permitted by law. • Users may freely distribute the URL that is used to identify this publication. • Users may download and/or print one copy of the publication from the University of Birmingham research portal for the purpose of private study or non-commercial research. • User may use extracts from the document in line with the concept of 'fair dealing' under the Copyright, Designs and Patents Act 1988 (?) • Users may not further distribute the material nor use it for the purposes of commercial gain. Where a licence is displayed above, please note the terms and conditions of the licence govern your use of this document. When citing, please reference the published version. Take down policy While the University of Birmingham exercises care and attention in making items available there are rare occasions when an item has been uploaded in error or has been deemed to be commercially or otherwise sensitive.
BACKGROUND Musculoskeletal (MSK) pain from common conditions such as back pain and osteoarthritis... more BACKGROUND Musculoskeletal (MSK) pain from common conditions such as back pain and osteoarthritis is a major cause of pain and disability. We previously developed a prognostic tool (STarT Back Tool) specifically for use in primary care to guide the management of patients with low back pain. Prognostic stratified care models involve matching treatments to the patient’s prognostic profile to support clinical decision-making in an effort to maximize treatment benefits, reduce harm and increase health care efficiency. A logical next step is to determine whether a similar model of prognostic stratified care might also have benefits for primary care patients with a much broader range of MSK pain presentations (back, neck, knee, shoulder and multi-site pain). OBJECTIVE The primary objective is to determine, in patients presenting with one of the five most common MSK pain presentations in UK primary care, whether stratified care involving use of the Keele STarT MSK Tool to allocate individu...
Background: Sciatica is a painful condition managed by a stepped care approach for most patients.... more Background: Sciatica is a painful condition managed by a stepped care approach for most patients. Currently, there are no decision-making tools to guide matching care pathways for patients with sciatica without evidence of serious pathology, early in their presentation. This study sought to develop an algorithm to subgroup primary care patients with sciatica, for initial decision-making for matched care pathways, including fast-track referral to investigations and specialist spinal opinion. Methods: This was an analysis of existing data from a UK NHS cohort study of patients consulting in primary care with sciatica (n = 429). Factors potentially associated with referral to specialist services, were identified from the literature and clinical opinion. Percentage of patients fast-tracked to specialists, sensitivity, specificity, positive and negative predictive values for identifying this subgroup, were calculated. Results: The algorithm allocates patients to 1 of 3 groups, combining information about four clinical characteristics, and risk of poor prognosis (low, medium or high risk) in terms of pain-related persistent disability. Patients at low risk of poor prognosis, irrespective of clinical characteristics, are allocated to group 1. Patients at medium risk of poor prognosis who have all four clinical characteristics, and patients at high risk of poor prognosis with any three of the clinical characteristics, are allocated to group 3. The remainder are allocated to group 2. Sensitivity, specificity and positive predictive value of the algorithm for patient allocation to fast-track group 3, were 51, 73 and 22% respectively. Conclusion: We developed an algorithm to support clinical decisions regarding early referral for primary care patients with sciatica. Limitations of this study include the low positive predictive value and use of data from one cohort only. Ongoing research is investigating whether the use of this algorithm and the linked care pathways, leads to faster resolution of sciatica symptoms.
Objectives: The STarT Back Tool has good predictive performance for non-specific low back pain in... more Objectives: The STarT Back Tool has good predictive performance for non-specific low back pain in primary care. We therefore aimed to investigate whether a modified STarT Back Tool predicted outcome with a broader group of musculoskeletal patients, and assessed the consequences of using existing riskgroup cut-points across different pain regions. Setting: Secondary analysis of prospective data from 2 cohorts: (1) outpatient musculoskeletal physiotherapy services (PhysioDirect trial n=1887) and (2) musculoskeletal primary-secondary care interface services (SAMBA study n=1082). Participants: Patients with back, neck, upper limb, lower limb or multisite pain with a completed modified STarT Back Tool (baseline) and 6-month physical health outcome (Short Form 36 (SF-36)). Outcomes: Area under the receiving operator curve (AUCs) tested discriminative abilities of the tool's baseline score for identifying poor 6-month outcome (SF-36 lower tertile Physical Component Score). Riskgroup cut-points were tested using sensitivity and specificity for identifying poor outcome using (1) Youden's J statistic and (2) a clinically determined rule that specificity should not fall below 0.7 (false-positive rate <30%). Results: In PhysioDirect and SAMBA, poor 6-month physical health was 18.5% and 28.2%, respectively. Modified STarT Back Tool score AUCs for predicting outcome in back pain were 0.72 and 0.79, neck 0.82 and 0.88, upper limb 0.79 and 0.86, lower limb 0.77 and 0.83, and multisite pain 0.83 and 0.82 in PhysioDirect and SAMBA, respectively. Differences between pain region AUCs were non-significant. Optimal cut-points to discriminate low-risk and medium-risk/high-risk groups depended on pain region and clinical services. Conclusions: A modified STarT Back Tool similarly predicts 6-month physical health outcome across 5 musculoskeletal pain regions. However, the use of consistent risk-group cut-points was not possible and resulted in poor sensitivity (too many with long-term disability being missed) or specificity (too many with good outcome inaccurately classified as 'at risk') for some pain regions. The draft tool is now being refined and validated within a new programme of research for a broader musculoskeletal population.
Traditionally, low back-related leg pain (LBLP) is diagnosed clinically as referred leg pain or s... more Traditionally, low back-related leg pain (LBLP) is diagnosed clinically as referred leg pain or sciatica (nerve root involvement). However, within the spectrum of LBLP, we hypothesised that there may be other unrecognised patient subgroups. This study aimed to identify clusters of patients with LBLP using latent class analysis and describe their clinical course. The study population was 609 LBLP primary care consulters. Variables from clinical assessment were included in the latent class analysis. Characteristics of the statistically identified clusters were compared, and their clinical course over 1 year was described. A 5 cluster solution was optimal. Cluster 1 (n 5 104) had mild leg pain severity and was considered to represent a referred leg pain group with no clinical signs, suggesting nerve root involvement (sciatica). Cluster 2 (n 5 122), cluster 3 (n 5 188), and cluster 4 (n 5 69) had mild, moderate, and severe pain and disability, respectively, and response to clinical assessment items suggested categories of mild, moderate, and severe sciatica. Cluster 5 (n 5 126) had high pain and disability, longer pain duration, and more comorbidities and was difficult to map to a clinical diagnosis. Most improvement for pain and disability was seen in the first 4 months for all clusters. At 12 months, the proportion of patients reporting recovery ranged from 27% for cluster 5 to 45% for cluster 2 (mild sciatica). This is the first study that empirically shows the variability in profile and clinical course of patients with LBLP including sciatica. More homogenous groups were identified, which could be considered in future clinical and research settings.
evaluating the predictive ability and clinical utility of the SBST in a population with exclusive... more evaluating the predictive ability and clinical utility of the SBST in a population with exclusively chronic low back pain. Purpose: To determine the predictive ability and prognostic accuracy of the SBST for persistent pain, self-reported disability and self-perceived global rating of change in an Australian population with exclusively chronic low back pain. Methods: The SBST was completed at baseline by 290 participants with dominantly axial non-specific low back pain of at least three months duration. Follow-up data was collected after one year (n ¼ 264) for pain severity (11-point numerical rating scale), disability (Roland Morris Disability Questionnaire) and global perceived change (7-point global rating of change scale). The follow-up measures were dichotomised into recovered and not recovered for analyses. The proportion of participants who were not recovered with respect to each follow-up measure was calculated at a cohort level and by baseline SBST risk subgroup. Risk ratios (RR) (using the low risk group as the reference group) were calculated and ROC analyses performed. Results: At baseline, the SBST characterised 82 participants (28.3%) as low risk, 116 (40.0%) as medium risk and 92 (31.7%) as high risk. Non-recovery rates at one year were 31.4% (n ¼ 83) for disability, 76.1% (n ¼ 201) for pain and 44.5% (n ¼ 117) for global perceived change. The predictive ability of the SBST was strongest for disability (RR medium risk group 2.30 (95% CI 1.28e4.10), p ¼ 0.003; RR high risk group 2.86 (95% CI 1.60e5.11), p 0.001) and weaker for pain (RR medium risk group 1.25 (95% CI 1.04e1.51), p ¼ 0.013; RR high risk group 1.26 (95% CI 1.03e1.52, p ¼ 0.020). The AUC for disability was acceptable at 0.71 (95% CI 0.64e0.77) for the SBST total score and 0.67 (95% CI 0.60e0.73) for the psychological subscale score. The AUC for pain was poor (0.63 (95% CI 0.55e0.71)) for both the total score and psychological sub-scale score. The SBST risk subgroups were unable to identify those who had rated themselves as improved or not improved at one year. Conclusion: Baseline stratification with the SBST provided some indication of overall disability risk but its ability to predict future disability was attenuated compared to that previously reported in UK primary care with variable duration low back pain. In this study the SBST was relatively poor in predicting future pain and was unable to discriminate between those who perceived themselves as improved or not at one year. Implications: The SBST should be applied with caution in patients presenting with chronic low back pain. Clinicians interested in predicting future pain or global perceived change should consider using alternative screening measures in this population. It is recommended that the SBST be used in context with the clinical examination and in conjunction with sound clinical reasoning, clinical intuition and expert judgement, not as a standalone tool.
Programme grants for applied research, Jun 1, 2023
Background: Usual primary care for patients with musculoskeletal pain varies widely and treatment... more Background: Usual primary care for patients with musculoskeletal pain varies widely and treatment outcomes are suboptimal. Stratified care involves targeting treatments according to patient subgroups, in the hope of maximising treatment benefit and reducing potential harm or unnecessary interventions. This programme developed a new prognostic stratified primary care approach, where treatments are matched to a patient's risk of future persistent pain and disability based on a prognostic tool, and compared this with usual care. Objectives: In four linked work packages, we refined and validated a prognostic tool [the Keele STarT MSK (Subgrouping for Targeted Treatment for Musculoskeletal pain) Tool] to identify risk of poor outcome and defined cutoff scores to distinguish patient risk subgroups (work package 1); defined and agreed new matched treatment options for each risk subgroup and developed a support package for delivery of stratified care (work package 2); tested the feasibility of delivering the stratified approach through a pilot randomised controlled trial and externally validated the prognostic tool (work package 3); and tested the effectiveness of the approach by comparing the clinical effectiveness and costeffectiveness of stratified primary care with that of usual care through a cluster randomised controlled trial with embedded health economic and qualitative studies (work package 4). Setting: General practices and linked musculoskeletal services in the West Midlands of England, UK. Participants: Adults registered with participating practices consulting with back, neck, shoulder, knee or multisite musculoskeletal pain, and clinicians involved in managing these patients. Design: The programme included the following work packages: work package 1-a prospective cohort study in 12 practices; work package 2-an evidence synthesis, consensus group workshops and qualitative studies; work package 3-a cluster feasibility and pilot trial in eight practices; and work viii NIHR Journals Library www.journalslibrary.nihr.ac.uk ABSTRACT package 4-a main cluster randomised controlled trial in 24 practices, with health economic analyses and process evaluation. Interventions: Stratified care comprised training general practitioners to use the tool and match patients to treatment options depending on their risk subgroup. Usual care comprised usual nonstratified primary care without formal stratification tools. Main outcome measures: Cohort primary end points included function (Short Form questionnaire-36 items physical component score) and pain intensity (numerical rating scale). The trial primary end point for patient outcomes was pain intensity (monthly for 6 months) (0-10 numerical rating scale). An audit of primary care electronic medical records evaluated the impact of stratified care on clinical decisionmaking regarding patient management. Results: Work package 1-the cohort study (n = 1890 patients) refined and validated a new 10-item tool with which to stratify patients with the five most common musculoskeletal pain presentations. The tool subgroups patients into three strata with different characteristics and prognoses. Work package 2: 17 treatment options were recommended-four for patients at low risk, 10 for patients at medium risk and 15 for patients at high risk. Work package 3: the feasibility and pilot trial included 524 patients, and the learning led to amendments to several tool items and a reduced set of treatments (14 in total). Work package 4: in the main trial, 1211 patients consented to data collection (534 in stratified care, 677 in usual care). Stratified primary care did not lead to statistically significant differences in the primary patient outcome of pain intensity [stratified care mean 4.4 (standard deviation 2.3) vs. usual care mean 4.6 (standard deviation 2.4); adjusted mean difference-0.16, 95% confidence interval-0.65 to 0.34; p = 0.535]. Where differences were observed, these were largely isolated to patients at high risk of poor outcome (the smallest subgroup), in favour of stratified care. Positive differences were, however, observed in general practitioner clinical decision-making, with increased provision of written selfmanagement information and referrals to physiotherapy, plus reductions in prescription medication. The economic evaluation demonstrated that costs of care were similar across trial arms (£6.85, 95% confidence interval-£107.82 to £121.54 more for stratified care), with incremental quality-adjusted life-years of 0.0041 (95% confidence interval-0.0013 to 0.0094), representing a net quality-adjusted life-year gain. Stratified care was associated with an incremental cost-effectiveness ratio of £1670 per additional quality-adjusted life-year gained. At a willingness-to-pay threshold (λ) of £20,000 per qualityadjusted life-year, the incremental net monetary benefit was £132 and the probability of stratified care being cost-effective was approximately 73%. The very small differences suggest caution in the interpretation of this result. The qualitative findings revealed that general practitioners felt stratified care had a positive role in informing clinical decision-making, helped them to give greater attention to psychosocial issues and take a more functional approach, and facilitated negotiations with patients about treatment options such as imaging. Limitations: The randomised controlled trial was not powered to detect differences between stratified and usual care for patients in each risk subgroup (low, medium and high) nor with each different musculoskeletal pain presentation. The stratified care electronic medical record template 'fired' only once per patient. Conclusions: The Keele STarT MSK Tool is a valid instrument with which to discriminate between, and predict outcomes of, primary care patients with musculoskeletal pain. Although the randomised trial showed no significant benefit in patient-reported outcomes compared with usual care, some aspects of clinical decision-making improved and the approach was cost-effective. Future work: The Keele STarT MSK Tool has been shared with over 1000 tool license requestees, leading to other work. Trial data sets have also led to other work, developing personalised prognostic models for back and neck pain patients (the European Union-funded BackUP project). The challenge remains how to improve outcomes for primary care patients with musculoskeletal pain. Trial registration: This trial is registered as ISRCTN15366334.
Link to publication on Research at Birmingham portal General rights Unless a licence is specified... more Link to publication on Research at Birmingham portal General rights Unless a licence is specified above, all rights (including copyright and moral rights) in this document are retained by the authors and/or the copyright holders. The express permission of the copyright holder must be obtained for any use of this material other than for purposes permitted by law. • Users may freely distribute the URL that is used to identify this publication. • Users may download and/or print one copy of the publication from the University of Birmingham research portal for the purpose of private study or non-commercial research. • User may use extracts from the document in line with the concept of 'fair dealing' under the Copyright, Designs and Patents Act 1988 (?) • Users may not further distribute the material nor use it for the purposes of commercial gain. Where a licence is displayed above, please note the terms and conditions of the licence govern your use of this document. When citing, please reference the published version. Take down policy While the University of Birmingham exercises care and attention in making items available there are rare occasions when an item has been uploaded in error or has been deemed to be commercially or otherwise sensitive.
Background: There is limited research on the economic burden of low back-related leg pain, includ... more Background: There is limited research on the economic burden of low back-related leg pain, including sciatica. The aim of this study was to describe healthcare resource utilisation and factors associated with cost and health outcomes in primary care patients consulting with symptoms of low back-related leg pain including sciatica. Methods: This study is a prospective cohort of 609 adults visiting their family doctor with low back-related leg pain, with or without sciatica in a United Kingdom (UK) Setting. Participants completed questionnaires, underwent clinical assessments, received an MRI scan, and were followed-up for 12-months. The economic analysis outcome was the quality-adjusted life year (QALY) calculated from the EQ-5D-3 L data obtained at baseline, 4 and 12-months. Costs were measured based on patient self-reported information on resource use due to back-related leg pain and results are presented from a UK National Health Service (NHS) and Societal perspective. Factors associated with costs and outcomes were obtained using a generalised linear model. Results: Base-case results showed improved health outcomes over 12-months for the whole cohort and slightly higher QALYs for patients in the sciatica group. NHS resource use was highest for physiotherapy and GP visits, and work-related productivity loss highest from a societal perspective. The sciatica group was associated with significantly higher work-related productivity costs. Cost was significantly associated with factors such as self-rated general health and care received as part of the study, while quality of life was significantly predicted by self-rated general health, and pain intensity, depression, and disability scores. Conclusions: Our results contribute to understanding the economics of low back-related leg pain and sciatica and may provide guidance for future actions on cost reduction and health care improvement strategies. Trial registration: 13/09/2011 Retrospectively registered; ISRCTN62880786.
Background: Musculoskeletal (MSK) pain from the five most common presentations to primary care (b... more Background: Musculoskeletal (MSK) pain from the five most common presentations to primary care (back, neck, shoulder, knee or multi-site pain), where the majority of patients are managed, is a costly global health challenge. At present, first-line decision-making is based on clinical reasoning and stratified models of care have only been tested in patients with low back pain. We therefore, examined the feasibility of; a) a future definitive cluster randomised controlled trial (RCT), and b) General Practitioners (GPs) providing stratified care at the point-ofconsultation for these five most common MSK pain presentations. Methods: The design was a pragmatic pilot, two parallel-arm (stratified versus non-stratified care), cluster RCT and the setting was 8 UK GP practices (4 intervention, 4 control) with randomisation (stratified by practice size) and blinding of trial statistician and outcome data-collectors. Participants were adult consulters with MSK pain without indicators of serious pathologies, urgent medical needs, or vulnerabilities. Potential participant records were tagged and individuals sent postal invitations using a GP point-of-consultation electronic medical record (EMR) template. The intervention was supported by the EMR template housing the Keele STarT MSK Tool (to stratify into low, medium and high-risk prognostic subgroups of persistent pain and disability) and recommended matched treatment options. Feasibility outcomes included exploration of recruitment and follow-up rates, selection bias, and GP intervention fidelity. To capture recommended outcomes including pain and function, participants completed an initial questionnaire, brief monthly questionnaire (postal or SMS), and 6-month follow-up questionnaire. An anonymised EMR audit described GP decision-making. Results: GPs screened 3063 patients (intervention = 1591, control = 1472), completed the EMR template with 1237 eligible patients (intervention = 513, control = 724) and 524 participants (42%) consented to data collection (intervention = 231, control = 293). Recruitment took 28 weeks (target 12 weeks) with > 90% follow-up retention (target > 75%). We detected no selection bias of concern and no harms identified. GP stratification tool fidelity failed to achieve a-priori success criteria, whilst fidelity to the matched treatments achieved "complete success". Conclusions: A future definitive cluster RCT of stratified care for MSK pain is feasible and is underway, following key amendments including a clinician-completed version of the stratification tool and refinements to recommended matched treatments.
Background: Musculoskeletal (MSK) pain represents a considerable worldwide healthcare burden. Thi... more Background: Musculoskeletal (MSK) pain represents a considerable worldwide healthcare burden. This study aimed to gain consensus from practitioners who work with MSK pain patients, on the most appropriate primary care treatment options for subgroups of patients based on prognostic risk of persistent disabling pain. Agreement was sought on treatment options for the five most common MSK pain presentations: back, neck, knee, shoulder and multisite pain, across three risk subgroups: low, medium and high. Methods: Three consensus group meetings were conducted with multidisciplinary groups of practitioners (n = 20) using Nominal Group Technique, a systematic approach to building consensus using structured in-person meetings of stakeholders which follows a distinct set of stages. Results: For all five pain presentations, "education and advice" and "simple oral and topical pain medications" were agreed to be appropriate for all subgroups. For patients at low risk, across all five pain presentations "review by primary care practitioner if not improving after 6 weeks" also reached consensus. Treatment options for those at medium risk differed slightly across pain-presentations, but all included: "consider referral to physiotherapy" and "consider referral to MSK-interface-clinic". Treatment options for patients at high risk also varied by pain presentation. Some of the same options were included as for patients at medium risk, and additional options included: "opioids"; "consider referral to expert patient programme" (across all pain presentations); and "consider referral for surgical opinion" (back, knee, neck, shoulder). "Consider referral to rheumatology" was agreed for patients at medium and high risk who have multisite pain. Conclusion: In addressing the current lack of robust evidence on the effectiveness of different treatment options for MSK pain, this study generated consensus from practitioners on the most appropriate primary care treatment options for MSK patients stratified according to prognostic risk. These findings can help inform future clinical decision-making and also influenced the matched treatment options in a trial of stratified primary care for MSK pain patients.
Objectives: The aim of this study was to describe and compare health economic outcomes [health-ca... more Objectives: The aim of this study was to describe and compare health economic outcomes [health-care utilization and costs, work outcomes, and health-related quality of life (EQ-5D-5L)] in patients classified into different levels-of-risk subgroups by the Keele STarT MSK Tool. Methods: Data on health-care utilization, costs and EQ-5D-5L were collected from a health-care perspective within a primary care prospective observational cohort study. Patients presenting with one (or more) of the five most common musculoskeletal pain presentations were included: back, neck, shoulder, knee or multi-site pain. Participants at low, medium and high risk of persistent disabling pain were compared in relation to mean health-care utilization and costs, health-related quality of life, and employment status. Regression analysis was used to estimate costs. Results: Over 6 months, the mean (S.D.) total health-care (National Health Service and private) costs associated with the low, medium, and highrisk subgroups were £132.92 (167.88), £279.32 (462.98) and £476.07 (716.44), respectively. Mean health-related quality of life over the 6-month period was lower and more people changed their employment status in the high-risk subgroup compared with the medium-and low-risk subgroups. Conclusions: This study demonstrates that subgroups of people with different levels of risk for poor musculoskeletal pain outcomes also have different levels of health-care utilization, health-care costs, health-related quality of life, and work outcomes. The findings show that the STarT MSK Tool not only identifies those at risk of a poorer outcome, but also those who will have more health-care visits and incur higher costs.
1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/formResponse?hl=en_US 3/22 yes: all prim... more 1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/formResponse?hl=en_US 3/22 yes: all primary outcomes were significantly better in intervention group vs control partly: SOME primary outcomes were significantly better in intervention group vs control no statistically significant difference between control and intervention potentially harmful: control was significantly better than intervention in one or more outcomes
BackgroundWhile there is a substantial body of knowledge about acute COVID-19, less is known abou... more BackgroundWhile there is a substantial body of knowledge about acute COVID-19, less is known about long-COVID, where symptoms continue beyond 4 weeks.AimTo describe longer-term effects of COVID-19 infection in children and young people (CYP) and identify their needs in relation to long-COVID.Design & settingThis study comprises an observational prospective cohort study and a linked qualitative study, identifying participants aged 8–17 years in the West Midlands of England.MethodCYP will be invited to complete online questionnaires to monitor incidences and symptoms of COVID-19 over a 12-month period. CYP who have experienced long-term effects of COVID will be invited to interview, and those currently experiencing symptoms will be asked to document their experiences in a diary. Professionals who work with CYP will be invited to explore the impact of long-COVID on the wider experiences of CYP, in a focus group. Descriptive statistics will be used to describe the incidence and rates of...
BackgroundPatients with musculoskeletal pain in different body sites share common prognostic fact... more BackgroundPatients with musculoskeletal pain in different body sites share common prognostic factors. Using prognosis to stratify and treatment match can be clinically and cost‐effective. We aimed to refine and validate the Keele STarT MSK Tool for prognostic stratification of musculoskeletal pain patients.MethodsTool refinement and validity was tested in a prospective cohort study, and external validity examined in a pilot cluster randomized controlled trial (RCT). Study population comprised 2,414 adults visiting U.K. primary care with back, neck, knee, shoulder or multisite pain returning postal questionnaires (cohort: 1,890 [40% response]; trial: 524). Cohort baseline questionnaires included a draft tool plus refinement items. Trial baseline questionnaires included the Keele STarT MSK Tool. Physical health (SF‐36 Physical Component Score [PCS]) and pain intensity were assessed at 2‐ and 6‐month cohort follow‐up; pain intensity was measured at 6‐month trial follow‐up.ResultsThe to...
Link to publication on Research at Birmingham portal General rights Unless a licence is specified... more Link to publication on Research at Birmingham portal General rights Unless a licence is specified above, all rights (including copyright and moral rights) in this document are retained by the authors and/or the copyright holders. The express permission of the copyright holder must be obtained for any use of this material other than for purposes permitted by law. • Users may freely distribute the URL that is used to identify this publication. • Users may download and/or print one copy of the publication from the University of Birmingham research portal for the purpose of private study or non-commercial research. • User may use extracts from the document in line with the concept of 'fair dealing' under the Copyright, Designs and Patents Act 1988 (?) • Users may not further distribute the material nor use it for the purposes of commercial gain. Where a licence is displayed above, please note the terms and conditions of the licence govern your use of this document. When citing, please reference the published version. Take down policy While the University of Birmingham exercises care and attention in making items available there are rare occasions when an item has been uploaded in error or has been deemed to be commercially or otherwise sensitive.
BACKGROUND Musculoskeletal (MSK) pain from common conditions such as back pain and osteoarthritis... more BACKGROUND Musculoskeletal (MSK) pain from common conditions such as back pain and osteoarthritis is a major cause of pain and disability. We previously developed a prognostic tool (STarT Back Tool) specifically for use in primary care to guide the management of patients with low back pain. Prognostic stratified care models involve matching treatments to the patient’s prognostic profile to support clinical decision-making in an effort to maximize treatment benefits, reduce harm and increase health care efficiency. A logical next step is to determine whether a similar model of prognostic stratified care might also have benefits for primary care patients with a much broader range of MSK pain presentations (back, neck, knee, shoulder and multi-site pain). OBJECTIVE The primary objective is to determine, in patients presenting with one of the five most common MSK pain presentations in UK primary care, whether stratified care involving use of the Keele STarT MSK Tool to allocate individu...
Background: Sciatica is a painful condition managed by a stepped care approach for most patients.... more Background: Sciatica is a painful condition managed by a stepped care approach for most patients. Currently, there are no decision-making tools to guide matching care pathways for patients with sciatica without evidence of serious pathology, early in their presentation. This study sought to develop an algorithm to subgroup primary care patients with sciatica, for initial decision-making for matched care pathways, including fast-track referral to investigations and specialist spinal opinion. Methods: This was an analysis of existing data from a UK NHS cohort study of patients consulting in primary care with sciatica (n = 429). Factors potentially associated with referral to specialist services, were identified from the literature and clinical opinion. Percentage of patients fast-tracked to specialists, sensitivity, specificity, positive and negative predictive values for identifying this subgroup, were calculated. Results: The algorithm allocates patients to 1 of 3 groups, combining information about four clinical characteristics, and risk of poor prognosis (low, medium or high risk) in terms of pain-related persistent disability. Patients at low risk of poor prognosis, irrespective of clinical characteristics, are allocated to group 1. Patients at medium risk of poor prognosis who have all four clinical characteristics, and patients at high risk of poor prognosis with any three of the clinical characteristics, are allocated to group 3. The remainder are allocated to group 2. Sensitivity, specificity and positive predictive value of the algorithm for patient allocation to fast-track group 3, were 51, 73 and 22% respectively. Conclusion: We developed an algorithm to support clinical decisions regarding early referral for primary care patients with sciatica. Limitations of this study include the low positive predictive value and use of data from one cohort only. Ongoing research is investigating whether the use of this algorithm and the linked care pathways, leads to faster resolution of sciatica symptoms.
Objectives: The STarT Back Tool has good predictive performance for non-specific low back pain in... more Objectives: The STarT Back Tool has good predictive performance for non-specific low back pain in primary care. We therefore aimed to investigate whether a modified STarT Back Tool predicted outcome with a broader group of musculoskeletal patients, and assessed the consequences of using existing riskgroup cut-points across different pain regions. Setting: Secondary analysis of prospective data from 2 cohorts: (1) outpatient musculoskeletal physiotherapy services (PhysioDirect trial n=1887) and (2) musculoskeletal primary-secondary care interface services (SAMBA study n=1082). Participants: Patients with back, neck, upper limb, lower limb or multisite pain with a completed modified STarT Back Tool (baseline) and 6-month physical health outcome (Short Form 36 (SF-36)). Outcomes: Area under the receiving operator curve (AUCs) tested discriminative abilities of the tool's baseline score for identifying poor 6-month outcome (SF-36 lower tertile Physical Component Score). Riskgroup cut-points were tested using sensitivity and specificity for identifying poor outcome using (1) Youden's J statistic and (2) a clinically determined rule that specificity should not fall below 0.7 (false-positive rate <30%). Results: In PhysioDirect and SAMBA, poor 6-month physical health was 18.5% and 28.2%, respectively. Modified STarT Back Tool score AUCs for predicting outcome in back pain were 0.72 and 0.79, neck 0.82 and 0.88, upper limb 0.79 and 0.86, lower limb 0.77 and 0.83, and multisite pain 0.83 and 0.82 in PhysioDirect and SAMBA, respectively. Differences between pain region AUCs were non-significant. Optimal cut-points to discriminate low-risk and medium-risk/high-risk groups depended on pain region and clinical services. Conclusions: A modified STarT Back Tool similarly predicts 6-month physical health outcome across 5 musculoskeletal pain regions. However, the use of consistent risk-group cut-points was not possible and resulted in poor sensitivity (too many with long-term disability being missed) or specificity (too many with good outcome inaccurately classified as 'at risk') for some pain regions. The draft tool is now being refined and validated within a new programme of research for a broader musculoskeletal population.
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